Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 469 - 479)

TUESDAY 7 DECEMBER 2004

DR ROBERTO SOLARI, DR MALCOLM BOYCE AND MR HARPAL KUMAR

  Q469  Chairman: Welcome to our second set of witnesses this morning. Once again, can I express our thanks for your co-operation with our inquiry. Would you briefly introduce yourselves?

  Dr Boyce: I am a physician, a clinical pharmacologist, and I manage a contract research organisation called Hammersmith Medicines Research, which is based at the Central Middlesex Hospital, an NHS hospital. It is a bit unusual for the private sector to be embedded in the public sector. I largely undertake evaluation of potential new medicines for the pharmaceutical industry.

  Dr Solari: I am Roberto Solari, Chief Executive of Medical Research Council Technology, the technology transfer arm of the Medical Research Council.

  Mr Kumar: I am Harpal Kumar, Chief Operating Officer of Cancer Research UK and Chief Executive of the Cancer Research Technology, which is the technology transfer and development arm of Cancer Research UK.

  Q470  Chairman: Can I ask you all to speak up; it is not particularly easy to hear in this room and we want to be sure of what you are saying. The MRC stated that it shares a desire to maintain public trust in the governance and practice of medical research. How do you feel this trust can be best achieved?

  Dr Solari: In matters of trust you need, as speakers this morning have said, transparency. People have to feel they know what is going on and have access to the information. They have to build this trust with all stakeholders in industry, and the public.

  Q471  Chairman: Do you think that genuine transparency is achievable within a situation where you have this tension in terms of competition and companies obviously wanting to succeed with their products? Is it something we could achieve in the way that you are suggesting you would like?

  Dr Solari: You have to look at the drug discovery process and the drug development process, and clinical trials as a very long and complex series of events, which can take anywhere from 15 years from early discovery right through to the product reaching the market. There are periods during that 15-year process where you have to keep things secret in order to protect your advantage over the competition, because this is a business. In the early stages, where you may have discovered a new compound or chemical entity that has some activity, there is still an awful lot of work to do before that early discovery becomes a product. You want to keep that secret, like any business would keep trade secrets to themselves. Coming to a certain point you do make disclosures and file patents, and patents are published. There is a period where just for the functioning of the industry you need to keep certain things secret, but later on in the process when it is appropriate and possible, that information becomes open and transparent. You have to look at the whole process.

  Dr Boyce: Can I emphasise something that did not come out clearly in the previous evidence? It is very important to separate the stages of drug development, which can broadly be described as early and late. Early clinical development is essentially part of research, whereas late clinical development once a product begins to emerge tends to be influenced much more by the marketing group. The early group, the research—in my years of experience of working within the industry, as a pharmaceutical physician working within the NHS doing clinical trials, setting them up around the world—the commitment and sense of altruism amongst researchers, whether they are voluntary researchers or in the clinics, is absolutely the same as it is for academia. Indeed, it is probably more transparent because there are those who work—certainly in my experience of trying to liaise with those in academia—they want the money and they want the funding, but they do not necessarily want to recognise the association, so it is a much more insidious relationship. The transparency is there in early drug development. I certainly have no problems whatsoever in recognising that. Occasionally, the industry is less than open about publication of results but we have to remember that the attrition rate is very high in early drug development, some would say as high as 80%, certainly the majority of molecules. Incidentally, I wanted the opportunity to comment on "me too" and your experience in Australia. Our unit works almost exclusively on new molecules. There are abundant new molecules coming through. If you think all the drugs coming through are patent extensions, you should come out and see our unit because that is not our experience. I could give a spirited defence of "me too" products because there is plenty of evidence that, when there are lots of "me too" products, the one that come on early to the market drop out and the ones that are developed as "me too" often are the ones that succeed. To get back to the publication, I have certainly run into difficulties with publishing work when I was based in the industry and in my current practice. I have had problems in recent years persuading companies to publish the work. They do not want to publish it because it is negative. They do not think it merits publishing, or they do not want their competitors to know that they are in a particular area of research. I battle against that. Often they are short sighted. You have to understand the pharmaceutical industry is a large organisation. They do not always have clear policies. You will get a decision from one person and a different one from another. Although the ethos may be towards publication in practice it does not always work out. One has to battle to get publications done but I have always succeeded in doing that and there are ways in which you could make that a bit more transparent. Ethics committees are burdened with lots of unnecessary things but one condition of ethical approval could be that the results are published. That is a gateway and it would be very easy to control all the clinical trials like that. Secondly, the European Clinical Trials Directive requires all clinical trials of investigational medicinal products to be registered, to get a Eudra CT number. That is going to be a marvellous way of monitoring the trials done within Europe and following them up to see how many of them get published. It will be owned by the European Commission and I do not think necessarily by the individual regulatory authorities but I do not know enough about that to comment.

  Q472  Dr Naysmith: You said that you tried slightly to justify not publishing negative results. Do you not think that not publishing negative results is dishonest? It is cheating, certainly.

  Dr Boyce: Or they are not interesting enough.

  Q473  Dr Naysmith: I am distinguishing between publishing an academic journal and a firm saying, "These are negative results."

  Dr Boyce: If it merits publication, it should be published. There are sometimes differences of opinion about whether something merits publication, even amongst academics.

  Q474  Dr Naysmith: I am not talking about something meriting publication in the sense of being a scientific paper that lots of people will consult. If you have a drug company doing research and it gets negative results, not to publish them, even if they have to publish them at your expense rather than through a journal, is dishonest.

  Dr Boyce: I would not say it is dishonest. It is not sensible. It is not in the interests of medicine in general.

  Mr Kumar: You have asked two questions, one about trust and one about transparency. With regard to the question of trust, our own experience in Cancer Research UK where we raise around £350 million every year from the British public is a testimony to the fact that the British public does have trust in medical research carried out in this country. On the general principle of is there trust in medical research, I would say yes. Clearly some of the disclosures or allegations that have been made over the last several weeks with regard to some of the practices in the pharmaceutical industry might affect that but I think it is unlikely to affect the generality of medical research. It is more about some specific practices. With regard to can we achieve transparency, I would argue that we could achieve sufficient transparency. We, as you know, have argued for a register of all clinical trials so that every clinical trial should be required to be registered centrally; and secondly for publication of all clinical trial results. There are probably ways in which the concerns of the pharmaceutical industry can be mitigated with regard to early phase studies but ultimately all trial results should be published and if that were done I think we would have sufficient transparency.

  Q475  Jim Dowd: You said there is general trust in medical research in this country. Is it not the case though that it depends who is carrying it out? I am sure that is true of Cancer Research UK, the British Heart Foundation and others, where they are seen to be a charity or at least not for profit, when they are doing it but when any of the large pharmaceutical companies do it is there not a higher degree of scepticism?

  Mr Kumar: The surveys we have seen ask the general question about research as opposed to the question about who is carrying it out. You see percentage numbers around the 70s and 80s in terms of general support for the carrying out of research, so that is the basis upon which I make my statement.

  Q476  Dr Naysmith: Do people know it is being carried out by Cancer Research?

  Mr Kumar: The surveys I am talking about are just generally about research without saying that we are commissioning the survey.

  Q477  Dr Naysmith: Dr Solari, in the written evidence you say that industry representatives contribute to the development of MRC policy and funding decisions at strategic and practical levels. How does this happen? Is there an equal, reciprocal arrangement? In other words, does the MRC attempt to shape drug firms' research policy or policy in other areas?

  Dr Solari: The MRC is governed by a council and there is one industry representative member of council which is a ministerial appointment. It is publicly advertised. That is one person out of about 20. I do not believe there is an undue influence but industry is one of the important partners for the MRC. The MRC has a number of partners. It has the Department of Health; it has universities, other research funders, medical charities and the UK public. What the MRC tries to do is to make sure that on all of its bodies, governance bodies and boards, there are representatives of all of our stakeholders. I think that is one of the great strengths of the MRC, that it is an independent body but that it interacts effectively with all of the bodies with whom it needs to interact. It is part of our remit to have representatives on our council and on our various boards, but I do not believe there is inappropriate influence. Do we influence them? I hope we do. The MRC is one of the greatest supporters of high quality medical research in the world, with 23 Nobel prizes so far awarded to MRC scientists or scientists supported by the MRC. The track record of the MRC is outstanding. I believe we have shaped, biomedical research in a global sense, so yes, I would be surprised if we have not influenced industry.

  Q478  Dr Naysmith: Does the Medical Research Council decide that maybe something is needed, a treatment or something, and look around to try and influence the pharmaceutical industry to provide that kind of research that will answer the problem that they are talking about?

  Dr Solari: I believe the sorts of clinical trials that the MRC does and supports are different to the clinical trials that the pharmaceutical industry does so we do not do trials on new drugs. You heard about some of them earlier—the Epsom salts for pre-eclampsia; the use of steroids for brain inflammation following head trauma. They were trials supported by the MRC.

  Q479  Dr Naysmith: Does the MRC initiate any of these? Do you have anyone looking around and saying, "There is this gap that needs to be filled and nobody is filling it. Can we help?"?

  Dr Solari: Yes, I believe we do. For example, prophylactic antibiotic treatment of young children with AIDS in Zambia . That was a gap that was seen by the MRC and the MRC supported that trial and showed that there was a real advantage to prophylactic use of co trimoxazole. Yes, I think the MRC does identify those needs. Sometimes they involve a drug that is made by a drug company and so we would ask the drug company to supply that drug for the trial. They are very willing to do that. The large, prospective use of statins to reduce heart attacks and stroke was such a study. It was done in partnership with a pharmaceutical company but it was to answer a very broad, unmet medical need or question for society.


 
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